Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S01)

PRIMARY OBJECTIVES:

I. To evaluate clinical accuracy (including clinical sensitivity, clinical specificity, false positive rate, and false negative rate) for the detection of cervical precancer/cancer and agreement/concordance (including positive percent agreement and negative percent agreement) on self-collected (SC) versus clinician collected (CC) samples for the following HPV genotype detections and groupings by Becton, Dickinson and Company (BD) Onclarity (trademark) HPV assay: Any high risk (HR) HPV genotype, HPV16, HPV18, HPV31, HPV45, HPV51, HPV52, HPV33/58, HPV35/39/68, HPV56/59/66, HPV16 and/or HPV18, other 12 HR-HPV types (grouped). (Group A) II. To conduct an observational study among women attending regular cervical cancer screening ("intended use population" for the at-home collection indication). (Group B)

EXPLORATORY OBJECTIVES:

I. To evaluate human factors affecting usability, acceptability, and preferences for self-collection. (Group A) II. To evaluate agreement/concordance (including positive percent agreement and negative percent agreement) on SC versus CC samples for the following HPV genotype detections and groupings by BD Onclarity™ HPV assay: Any HR HPV genotype, HPV16, HPV18, HPV31, HPV45, HPV51, HPV52, HPV33/58, HPV35/39/68, HPV56/59/66, HPV16 and/or HPV18, other 12 HR-HPV types (grouped). (Group B) III. To evaluate human factors affecting usability, acceptability, and preferences for self-collection. (Group B)

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP A: Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.

GROUP B: Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of 1 or 2 cervical test samples. Patients may undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.

After completion of study intervention (one time), laboratory results available within 30 days are collected for study analysis purposes.

Inclusion criteria

• GROUP A: Willingness and ability to provide a documented informed consent
• GROUP A: Is 25 years or older
• GROUP A: Has an intact cervix
• GROUP A: Has had a referral for colposcopy or cervical excisional procedure in which routine cervical cancer screening has included positive HPV testing (HPV primary screening, co-testing, or atypical squamous cells of undetermined significance [ASC-US] cytology triage) or abnormal cytology performed within the past 12 months preceding the referral visit
• GROUP A: Willing and able to undergo colposcopy, and if clinically indicated for SOC purposes, a biopsy, endocervical curettage, and/or a cervical excisional procedure, as applicable
• GROUP B: Willingness and ability to provide a documented informed consent
• GROUP B: Is 25 years or older
• GROUP B: Has an intact cervix
• GROUP B: Eligible for regular cervical cancer screening by current national guidelines

Exclusion criteria

• GROUP A: Is pregnant when presenting for the referral visit or gave birth within the past 3 months
• GROUP A: Has a known history of excisional or ablative therapy to the cervix (e.g., loop electrosurgical excision procedure [LEEP], cone biopsy, cervical laser surgery, cryotherapy, thermal ablation) in the last 12 months prior to the referral visit
• GROUP A: Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records
• GROUP A: Known medical conditions that, in the opinion of the investigator, preclude study participation
• GROUP A: Previous participation in the SHIP trial (participation is defined as completing the self-collection sampling) or another cervical cancer screening study that involved vaginal sampling within the past 12 months
• GROUP A: Is experiencing unusual bleeding or pelvic pain
• GROUP B: Is known to be pregnant when presenting for the screening visit or gave birth within the past 3 months
• GROUP B: Has a known history of excisional or ablative therapy to the cervix (e.g., LEEP, cone biopsy, cervical laser surgery, cryotherapy, thermal ablation) in the last 12 months prior to the screening visit
• GROUP B: Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records
• GROUP B: Known medical conditions that, in the opinion of the investigator, preclude study participation
• GROUP B: Previous participation in the SHIP Trial (participation is defined as completing the self-collection sampling) or another cervical cancer screening study that involved vaginal sampling within the past 12 months
• GROUP B: Is experiencing any bleeding (including menstruation) or pelvic pain
• GROUP B: Is experiencing any active vaginal infection or has used any vaginal products in 48 hours previous to study sample collection